Computer Assisted Detection of Neoplasia During Colonoscopy Evaluation

Trial Title: Computer Assisted Detection of Neoplasia During Colonoscopy Evaluation

NCT ID: NCT05888623

Condition: Colorectal Neoplasms

Conditions: Official terms:
Colorectal Neoplasms

Conditions: Keywords:
colonoscopy
artificial intelligence
adenoma
Veterans
quality assurance

Study type: Observational

Overall status: Enrolling by invitation

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Device
Intervention name: Computer Assisted Detection
Description: Computer-aided polyp detection system that utilizes artificial intelligence (AI) during colonoscopy
Arm group label: Computer Assisted Detection

Other name: GI Genius Intelligent Endoscopy Module (Medtronic)

Summary: The purpose of this study is to evaluate the effect of artificial intelligence systems used during colonoscopy on the detection of precancerous polyps in the colon.

Detailed description: Colonoscopy is a key diagnostic and therapeutic procedure for the prevention of colorectal cancer incidence and mortality. Central to colonoscopy's effectiveness is the identification and removal of colorectal neoplasia, including adenomatous polyps and sessile serrated lesions. The endoscopist's adenoma detection rate (ADR), classically defined as the proportion of screening colonoscopies in which one or more adenomas are detected, has been demonstrated to be strongly inversely associated with their patients' risk of post-colonoscopy colorectal cancer. Therefore, improving adenoma detection is a major target of quality assurance efforts. In 2022, the FDA approved the first artificial intelligence (AI) system for computer assisted detection (CADe) of colorectal neoplasia (also known as colorectal polyps). These CADe devices project an image on the endoscopy monitor (i.e., a bounding box) to alert the endoscopist to the presence of a suspected polyp within the colon. Initial studies, including randomized controlled trials, have demonstrated that use of CADe systems result in a significant improvement in adenoma detection, with a reduction in the miss rate of adenomas (i.e., fewer adenomas are found on a second colonoscopy when the first colonoscopy was performed with a CADe system compared to when the first colonoscopy did not use CADe). However, more recent studies have not demonstrated a clear benefit of these devices. Moreover, most of the additional adenomas that are detected are diminutive polyps, the vast majority of which are thought to be of minimal, if any, clinical significance. When multiple adenomas are detected during colonoscopy, current guidelines recommend repeating colonoscopy sooner than would otherwise be recommended. Also, the CADe systems may have unintended consequences, such as creating alert fatigue through false alarms or negatively impacting training of gastroenterology fellows. As part of ongoing quality assurance efforts, the Veterans Health Administration's (VHA) National Gastroenterology and Hepatology Program (NGHP) purchased over 100 Medtronic GI Genius CADe devices in late 2022. As funds were not available to supply the CADe systems to all VHA medical centers, these devices were allocated to randomly selected medical centers across the United States. With the introduction of the CADe devices within the VHA, the NGHP will evaluate the quantitative and qualitative impact and outcomes of use of CADe within VHA medical centers. The NGHP has built a colonoscopy quality dashboard that reports adenoma detection rates for facilities and individual endoscopists at VHA medical centers. For select medical centers, additional quality metrics are also available (e.g., colonoscope withdrawal time, adenomas per colonoscopy, polyps per colonoscopy). Using these data, outcomes will be compared within facilities (i.e., pre- vs. post-CADe) and between facilities (i.e., facilities with CADe vs. facilities without CADe). Endoscopists at medical centers with CADe devices will be surveyed and interviewed about their use of and satisfaction with these devices. The initial evaluation will compare outcomes at the facility level. Subsequent analyses will compare outcomes at the individual endoscopist level.

Criteria for eligibility:

Study pop:
Veterans undergoing colonoscopy for any indication at VA facilities across the United States.

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - Colonoscopy performed at a Veterans Affairs (VA) medical center Exclusion Criteria: - Colonoscopy performed at VA medical centers that acquired computer-assisted detection artificial intelligence devices through non-random assignment - Colonoscopy performed at a VA medical center where pathology results are not available

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: VA Puget Sound Health Care System

Address:
City: Seattle
Zip: 98108
Country: United States

Start date: October 1, 2022

Completion date: September 30, 2024

Lead sponsor:
Agency: VA Puget Sound Health Care System
Agency class: U.S. Fed

Collaborator:
Agency: VA Salt Lake City Health Care System
Agency class: U.S. Fed

Collaborator:
Agency: San Francisco Veterans Affairs Medical Center
Agency class: U.S. Fed

Source: VA Puget Sound Health Care System

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05888623